Clinical Trial

Aom0304 in Adult Patients With Symptomatic Hypertrophic Cardiomyopathy

Not Yet Recruiting Phase 2
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Summary
The goal of this clinical trial is designed to characterise the safety, tolerability, efficacy, and PK of Aom0304 across oHCM and nHCM populations and to inform dose selection for future Phase 3 development. The main questions it aims to answer are: 1. Which dose is safe and tolerant of Aom0304 in participants with HCM? 2. Which dose is effective of 12 weeks of Aom0304 treatment in participants with oHCM or nHCM? Researchers will compare different doses of Aom0304 to see which works best. All participants will receive Aom0304, but at different dose levels depending on which cohort they joined. Participants will: 1. Undergo screening up to 28 days before enrollment to confirm eligibility 2. Adjust dose every 2 weeks assessed by the Investigator according to predefined criteria at Titration Phase (Week 1 Day 1 to Week 8). 3. Continuation of the last tolerated and effective dose; no further escalation is permitted at Maintenance Phase (Week 8 to Week 12). 4. Study drug discontinued and follow up at Off-treatment Follow-up Period (at the end of Week 12 to Week 16).
Trial Details
NCT Number NCT07675668
Lead Sponsor Amckaus PTY LTD.
Collaborators: Novotech (Australia) Pty Limited
Conditions Hypertrophic Cardiomyopathy (HCM), Obstructive HCM (oHCM), Non-obstructive HCM (nHCM)
Enrollment 56 participants
Start Date 2026-10-01
Primary Completion 2027-12-30 (estimated)
Study Completion 2028-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-30